An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Trial Details

NCT ID
NCT05939414
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • AAA617
  • piflufolastat (18F)
  • gallium (68Ga) gozetotide (25μg)
Locations (sample)
  • Fayetteville, Arkansas, United States|36.06258,-94.15743
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Palo Alto, California, United States|37.44188,-122.14302
  • San Francisco, California, United States|37.77493,-122.41942

Key Eligibility Criteria

  • Histologically confirmed prostate cancer prior to randomization
  • Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-o…
  • Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or pifl…
  • At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET/CT informatio…

For full eligibility, visit ClinicalTrials.gov.

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